Regulatory Affairs Manager

Job not on LinkedIn

🔥 40 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Fresenius Kabi

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Fresenius Kabi is a global healthcare company that develops, manufactures, and supplies lifesaving medicines, medical nutrition products, and medical technologies for critically and chronically ill patients. Their portfolio includes IV drugs and infusion therapies (anesthetics, oncology, anti-infectives, critical care), specialized parenteral and enteral nutrition, MedTech devices for anesthesia monitoring, blood and cell therapies, and accessible biopharmaceuticals. The company emphasizes high quality, patient safety, broad global presence, and sustainability while supporting healthcare professionals and improving access to care worldwide.

📋 Description

• Manage lifecycle and post-approval activities for assigned products under supervision • Support development and execution of global regulatory strategies and integrated plans for biosimilar products • Coordinate preparation, review and delivery of submission documents and regulatory data • Manage submission workstreams through approval, including planning, readiness tracking, publishing coordination, responses to questions and post-approval commitments • Coordinate cross-functional dossier teams and maintain timelines, dependencies, risks, decisions and action items • Contribute to regulatory storylines, briefing documents, consultations and submission dossiers • Support Health Authority interactions, including meeting requests, briefing packages, rehearsals, minutes and follow-up • Ensure Health Authority feedback and regulatory commitments are documented, communicated and implemented in project plans • Support regional activities and interactions with FDA, EMA and other Health Authorities • Provide guidance to Affiliates on local submissions, lifecycle management and regulatory constraints • Contribute regulatory input to launch readiness activities, including labeling, packaging and artwork • Partner with Regulatory Operations on systems, processes and technologies • Monitor submission readiness, identify risks and recommend mitigations or escalation • Maintain regulatory affairs databases • Monitor the regulatory environment and communicate relevant changes and emerging requirements • Coordinate third-party regulatory collaborators and track deliverables • Interface with regulatory groups and company functions and support the Regulatory Sub-team • Support less-experienced colleagues; no direct reports • Perform additional responsibilities as assigned

🎯 Requirements

• Bachelor’s degree in life science or a related discipline • At least 6 to 8 years of relevant Regulatory Affairs experience; substantial experience in biologics or biosimilars is preferred • Experience contributing to international or regional regulatory submissions, preferably including a US BLA, EU MAA or comparable new-product application • Experience working in cross-functional development project teams and implementing regulatory strategy plans • Experience preparing documentation for Health Authority interactions and supporting meeting rehearsals and follow-up • Knowledge of biological development, clinical trial application requirements and product lifecycle management • Working understanding of the contribution of Regulatory Affairs to the pharmaceutical business and the ability to implement regulatory strategy • Ability to coordinate multiple submission workstreams and projects across development and lifecycle stages • Excellent written and spoken communication, interpersonal, organizational and stakeholder-management skills • Strong attention to detail while maintaining awareness of timelines, dependencies and overall objectives • Independent, self-motivated, proactive, goal-oriented and pragmatic working style, with appropriate escalation of strategic issues • Ability to collaborate effectively in cross-functional and multicultural teams and coordinate contributors without formal authority • Strong customer orientation and commitment to quality and compliance

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